Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:50 PM
Study NCT ID:
NCT06375460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects will wear a continuous glucose monitor and activity watch for study duration. Subjects will be micro-randomized once daily for 90 days to receive app prompts regarding nutrition or physical activity.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2024-03-14', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose time above 180mg/dL', 'timeFrame': 'daily during micro randomized trial, 90 days', 'description': 'measured using continuous glucose monitor'}, {'measure': 'Mean daily glucose', 'timeFrame': 'daily during micro randomized trial, 90 days', 'description': 'measured using continuous glucose monitor; mg/dL'}, {'measure': 'Maximum daily glucose', 'timeFrame': 'daily during micro randomized trial, 90 days', 'description': 'measured using continuous glucose monitor; mg/dL'}, {'measure': 'Minimum daily glucose', 'timeFrame': 'daily during micro randomized trial, 90 days', 'description': 'measured using continuous glucose monitor; mg/dL'}, {'measure': 'Glucose coefficient of variability', 'timeFrame': 'daily during micro randomized trial, 90 days', 'description': 'measured using continuous glucose monitor'}, {'measure': 'Mean amplitude of glycemic excursions', 'timeFrame': 'daily during micro randomized trial, 90 days', 'description': 'measured using continuous glucose monitor'}, {'measure': 'Hemoglobin A1c', 'timeFrame': 'through study completion, 6 months average', 'description': 'lab-based measure to assess longer-term glycemic control, collected at study visit'}, {'measure': 'Fasting glucose', 'timeFrame': 'through study completion, 6 months average', 'description': 'lab-based measure to assess glycemic control, collected at study visit'}, {'measure': 'Objective physical activity (step count)', 'timeFrame': 'daily during micro randomized trial, 90 days;', 'description': 'step count measured using the Fitbit physical activity tracker'}, {'measure': 'Objective physical activity (moderate-vigorous physical activity)', 'timeFrame': 'daily during micro randomized trial, 90 days;', 'description': 'moderate-vigorous physical activity (\\>100 steps per minute) will be measured using Fitbit activity tracker'}, {'measure': 'Self-reported physical activity', 'timeFrame': 'through study completion, 6 months average', 'description': 'assessed using PACE+ Adolescent Physical Activity Measure (PACE+) questionnaire to determine days with at least 60 minutes of moderate-vigorous physical activity per week. score ranges from 0-14; lower scores indicate less achievement of physical activity guidelines'}, {'measure': 'Diet quality', 'timeFrame': 'through study completion, 6 months average', 'description': '24-hour dietary recall will be collected by study staff, who will use the Automated Self Administered 24 Hour Dietary Recall Assessment Tool (ASA24) to record data for diet quality assessment'}, {'measure': 'Capability', 'timeFrame': 'through study completion, 6 months average', 'description': 'Assessed via the Diabetes Empowerment Scale (DES), a measure of self-efficacy. Average score ranges from 28-140; higher scores indicate greater diabetes empowerment'}, {'measure': 'Healthmine app use', 'timeFrame': 'during microrandomized trial, observational period', 'description': 'Percent of days with app use, per study period will be determined.'}, {'measure': 'Continuous glucose monitor use use', 'timeFrame': 'during microrandomized trial, observational period', 'description': 'Defined as percent of days with CGM data available, per study period.'}, {'measure': 'Motivation to engage in diabetes self-management', 'timeFrame': 'through study completion, 6 months average', 'description': 'Measured via Treatment Self-Regulation Questionnaire (TSRQ). score ranges from 15-105; scoring is based on and average between subscales of intrinsic vs. extrinsic motivation.'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': 'through study completion, 6 months average', 'description': 'weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Diabetes distress', 'timeFrame': 'through study completion; 6 months average', 'description': 'Measured via Problem Areas in Diabetes Scale (PAID-5). Score ranges from 0-20; a total score of 8 or more indicates possible diabetes related emotional distress.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Lifestyle', 'Hyperglycemia', 'Physical Inactivity']}, 'descriptionModule': {'briefSummary': 'This is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. The goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with T2D. Glycemic control will be monitored using Continuous Glucose Monitors (CGM), and health behavior data will be collected via a Fitbit activity tracker and a research app (Healthmine). Participants will be prompted to view and reflect on glycemic trends and health behavior data (Fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the Healthmine app and engagement with CGM in the following 90-day observation period.', 'detailedDescription': 'The objective of REFLECT2D (Real-time Engagement For Learning to Effectively Control Type 2 Diabetes) is to evaluate whether pairing real-time glycemic and health behavior data leads to improved glycemic control among adolescents and young adults with type 2 diabetes. Participants will use a mobile app that integrates continuous glucose monitor data, Fitbit activity tracker data, and diet logging, with the aim of increasing capability to interpret glycemic data (including impacts of physical activity and dietary intake), providing opportunity to plan and implement behavior change, and increasing motivation to engage in health behaviors. After a session with a Registered Dietitian and Diabetes Educator who will support participants in forming diet and activity goals, a 90-day micro-randomized trial (MRT) period will involve once daily randomization of each participant to: 1) physical-activity focused prompt, 2) dietary intake-focused prompt, or 3) no prompt. Prompts will include reviews of glycemic trends in the past 24 hours (e.g., periods of hyperglycemia, max glucose) and will ask participants to use visual summaries of activity or diet and glucose to reflect on and revise their behavioral management goals as needed. After the MRT, a 90-day observation period without prompts but with ongoing availability of continuous glucose monitor data, Fitbit, and Healthmine app will examine persistence of glycemic and behavior changes. In addition to daily micro-randomization, participants will be randomized 1:1 at study start to proactive outreach from the study team in the case of 3 or more days of missing data, versus no outreach for missing data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes\n* HbA1c ≥7.0%, stable medication use\n* HbA1c 6.0-6.9% without short-acting insulin, any other stable diabetes medication use\n* English-speaking (app in English)\n\nExclusion Criteria:\n\n* Current pregnancy\n* Hydroxyurea use (CGM sensor inaccuracies)\n* Cognitive impairment or severe psychiatric condition that could interfere with participation in behavioral intervention for diabetes self-management\n* Current or previously diagnosed eating disorder'}, 'identificationModule': {'nctId': 'NCT06375460', 'acronym': 'REFLECT2D', 'briefTitle': 'Real-time Engagement for Learning to Effectively Control Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Real-time Engagement for Learning to Effectively Control Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'STUDY24020141'}, 'secondaryIdInfos': [{'id': '1R01DK137803-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK137803-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Activity Focused App Prompt', 'description': 'The app prompts will ask participants what went well, or did not go well with their physical activity in the previous 24 hours in relation to their blood glucose numbers.', 'interventionNames': ['Behavioral: Focused App Prompt']}, {'type': 'EXPERIMENTAL', 'label': 'Diet Focused App Prompt', 'description': 'The app prompts will ask participants what went well, or did not go well with their diet in the previous 24 hours in relation to their blood glucose numbers.', 'interventionNames': ['Behavioral: Focused App Prompt']}, {'type': 'EXPERIMENTAL', 'label': 'No App Prompt', 'description': 'No app prompt will be sent to the participant', 'interventionNames': ['Behavioral: No App Prompt']}, {'type': 'EXPERIMENTAL', 'label': 'Outreach for Missing Data', 'description': 'Participants will be randomized to receive proactive outreach by the study team in the case of 3 or more days of missing CGM data, versus no proactive outreach', 'interventionNames': ['Behavioral: Outreach for Missing Data']}], 'interventions': [{'name': 'Focused App Prompt', 'type': 'BEHAVIORAL', 'description': 'Prompts are designed to develop knowledge and self-efficacy in diabetes-related health behaviors (capability). The paired glycemic and behavior data will provide the opportunity to reflect and to plan diet or exercise for the following day (self-reflective motivation).', 'armGroupLabels': ['Diet Focused App Prompt', 'Physical Activity Focused App Prompt']}, {'name': 'No App Prompt', 'type': 'BEHAVIORAL', 'description': 'No app prompts are designed to assess whether health behaviors are affected without being prompted to reflect and change those behaviors related to glycemic control.', 'armGroupLabels': ['No App Prompt']}, {'name': 'Outreach for Missing Data', 'type': 'BEHAVIORAL', 'description': 'For participants randomized to proactive outreach, after 3 or more days of missing CGM data, the study team will reach out to participants by phone and/or text message to troubleshoot and support participants in re-connecting with CGM and apps. For participants randomized to not receive proactive outreach, participants will be instructed to reach out to the study team at their discretion when help is needed related to CGM or app connection.', 'armGroupLabels': ['Outreach for Missing Data']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Mary Ellen Vajravelu, MD', 'role': 'CONTACT', 'email': 'vajravelume@upmc.edu', 'phone': '412-692-6533'}, {'name': 'Margaret Zupa, MD', 'role': 'CONTACT', 'email': 'zupamf@upmc.edu'}], 'overallOfficials': [{'name': 'Mary Ellen Vajravelu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, appendices)', 'accessCriteria': 'proposals should be directed to vajravelume@upmc.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dartmouth College', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'San Diego State University', 'class': 'OTHER'}, {'name': 'Emory University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mary Ellen Vajravelu, MD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}